Last updated: October 18, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting
Phase
2/3
Condition
Congestive Heart Failure
Chest Pain
Hyponatremia
Treatment
Usual care
Prednisone arm
Clinical Study ID
NCT05668676
APHP220428
2022-001604-17
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18 to 85 years of age
- Unplanned ED visit within the 12 hours prior to Screening with acute or worseningdyspnea and/or orthopnea, and Pulmonary congestion on chest X-ray or lung ultrasound.
- All measures from presentation to randomization of systolic blood pressure ≥ 100 mmHg,and of heart rate ≥ 60 bpm.
- Written informed consent to participate in the study.
- Affiliation to a french social security system (beneficiary or legal)
- Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP > 1,500 pg/mL or BNP>375 pg/mL and CRP > 40 mg/L
- Patient agrees for follow-up visit at the hospital at day 7 in case of earlierdischarge and Day 30.
Exclusion
Exclusion Criteria:
- Anticipated life expectancy less than 6 months
- Mechanical ventilation (not including CPAP/BIPAP) prior to Screening.
- Significant pulmonary disease contributing substantially to the patients' dyspnea suchas FEV1< 1 liter or need for chronic systemic or non- systemic steroid therapy, or anykind of primary right heart failure such as primary pulmonary hypertension orrecurrent pulmonary embolism.
- Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiacresynchronization therapy (CRT) device implantation within 3 months, or percutaneoustransluminal coronary intervention (PTCI), within 1 month prior to inclusion.
- Index Event (admission for AHF) triggered primarily by a correctable etiology such assignificant arrhythmia (e.g., sustained ventricular tachycardia, or atrialfibrillation/flutter with sustained ventricular response >130 beats per minute, orbradycardia with sustained ventricular arrhythmia <45 beats per minute), infection,severe anemia, acute coronary syndrome, pulmonary embolism, exacerbation of COPD,planned admission for device implantation or severe non-adherence leading to verysignificant fluid accumulation prior to admission and brisk diuresis after admission.Troponin elevations without other evidence of an acute coronary syndrome are not anexclusion.
- Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophicobstructive cardiomyopathy.
- History of heart transplant or on a transplant list, or using or planned to beimplanted with a ventricular assist device.
- Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior toscreening that is untreated.
- Presence at screening of any hemodynamically significant valvular stenosis orregurgitation, except mitral or tricuspid regurgitation secondary to left ventriculardilatation, or the presence of any hemodynamically significant obstructive lesion ofthe left ventricular outflow tract.
- Primary liver disease considered to be life threatening (defined by a prothrombin time < 30%)
- eGFR < 30 mL/min/1.73m2 or eGFR > 80 mL/min/1.73m2 (as estimated by the simplifiedMDRD formula) at inclusion or history of dialysis.
- Systemic steroid therapy, within 30 days from inclusion.
- Inability to consent, or patient under guardianship measure
- Participation in another intervention trial in the past 30 days
- Anticipated non-adherence to study protocol or follow-up.
- Pregnant or nursing (lactating) women.
- Known hypersensitivity to steroids or constituents of prednisone tablets (excipients)
- Psychotic states not yet controlled by treatment
- Concomitant administration of live vaccines and up to 3 months before end ofcorticotherapy administration
- Patient under legal protection measure (tutorship or curatorship) and patient deprivedof freedom
- Persons subject to psychiatric care without their consent
Study Design
Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Usual care
Phase: 2/3
Study Start date:
February 16, 2023
Estimated Completion Date:
March 31, 2024
Study Description
Connect with a study center
Emergency department Hospital Pitié-Salpêtrière
Paris, 75013
FranceActive - Recruiting
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